Meige SyndromeNCT04618887
A Comparative Study of GPI's DBS and Pallidotomy in the Treatment of Meige Syndrome
An observational study of Meige Syndrome and Meigs Syndrome, run by Peking University People's Hospital at 1 site in China.
Trial summary
In this study, we will compare the degree of postoperative symptom improvement, postoperative complication rate, postoperative quality of life improvement degree of patients with Meige syndrome undergoing pallidotomy (unilateral globus palliotomy) and deep brain stimulation (unilateral globus pallidus) ,in order to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Meige Syndrome, Meigs Syndrome, Meige Disease
- What is being tested?
- pallidotomy and deep brain stimulation
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Lack of incidence of Meige sydrome，and also lack of efficient of DBS or pallidotomy of Meige Syndrome. We try to collect more data as we can. We initially established a population of 100.
Who may be able to join
- Patients confirmed Meige sydrome
Who cannot join
- Patients who cannot finish the neurosurgery or the postoperative evaluation
Trial locations and contacts
1 site in 1 country.
About this study
In this study, we will compare the degree of postoperative symptom improvement, postoperative complication rate, postoperative quality of life improvement degree of patients with Meige syndrome undergoing pallidotomy (unilateral globus palliotomy) and deep brain stimulation (unilateral globus pallidus) ,in order to get the conclusion of the comparison of the clinical efficacy of the two surgical plans. In addition, possible predictive factors such as age, gender, age of onset, length of disease course, scale baseline score, preoperative brain PET-CT function analysis and other possible predictive factors are added for analysis, in order to find predictive factors that can guide the choice of surgical options.
- Conditions
- Meige Syndrome, Meigs Syndrome, Meige Disease, Meig Syndrome, Blepharospasm, Blepharospasm of Left Eyelid
- Being tested
- pallidotomy, deep brain stimulation
- Keywords
- deep brain stimulation, DBS, DBNL, GPi, pallidotomy
- Medical subject headings
- Meige Syndrome, Meigs Syndrome, Lymphedema, Hereditary, II, Blepharospasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pallidotomyProcedure or surgery
deep brain nuclei lesion of GPi
deep brain stimulationProcedure or surgery
deep brain stimulation of GPi
| Study group | Role | What they receive |
|---|---|---|
| Meige sydrome patients | Not described Receives: Procedure: pallidotomy; Procedure: deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom
spasm of eyelid
Measured: 2 years
complications
Postoperative complications
Measured: 2 years
Secondary outcomes (2)
quality of life
Evaluate using SF-36
Measured: 2 years
depression scale
Evaluate using Hamilton Depression Scale
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start1 Jan 2020
- Primary completionNov 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meige SyndromeStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Ruen, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618887
- Sponsor's protocol ID
- MeigeSyndrome
- Status last verified
- Nov 2020
- First submitted
- 1 Nov 2020
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of GPI's DBS and Pallidotomy in the Treatment of Meige Syndrome
- ClinicalTrials.gov ID
- NCT04618887
- Acronym / sponsor ID
- MeigeSyndrome
- Conditions
- Meige Syndrome, Meigs Syndrome, Meige Disease, Meig Syndrome, Blepharospasm, Blepharospasm of Left Eyelid
- Keywords
- deep brain stimulation, DBS, DBNL, GPi, pallidotomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 6 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, we will compare the degree of postoperative symptom improvement, postoperative complication rate, postoperative quality of life improvement degree of patients with Meige syndrome undergoing pallidotomy (unilateral globus palliotomy) and deep brain stimulation (unilateral globus pallidus) ,in order to get the conclusion of the comparison of the clinical efficacy of the two surgical plans. In addition, possible predictive factors such as age, gender, age of onset, length of disease course, scale baseline score, preoperative brain PET-CT function analysis and other possible predictive factors are added for analysis, in order to find predictive factors that can guide the choice of surgical options.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Meige sydrome patients | – | Procedure: pallidotomy, Procedure: deep brain stimulation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Lack of incidence of Meige sydrome，and also lack of efficient of DBS or pallidotomy of Meige Syndrome. We try to collect more data as we can. We initially established a population of 100.
Key inclusion criteria (1 listed)
- Patients confirmed Meige sydrome
Key exclusion criteria (1 listed)
- Patients who cannot finish the neurosurgery or the postoperative evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pallidotomydeep brain nuclei lesion of GPi | Procedure or surgery | Meige sydrome patients |
| deep brain stimulationdeep brain stimulation of GPi | Procedure or surgery | Meige sydrome patients |
Primary outcome
Symptom
Time frame: 2 years
spasm of eyelid
complications
Time frame: 2 years
Postoperative complications
2 secondary outcomes
quality of life
Time frame: 2 years
depression scale
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Meige Syndrome
RecruitingObservational study
Brain Networks in Dystonia
Spasmodic Dysphonia, Singer's Dystonia
Recruiting
Bilateral Single-Electrode VO Combined With STN-DBS for Treating Meige Syndrome
Meige Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meige Syndrome and Meigs Syndrome, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.